ADALAT CC Drug Patent Profile

When do Adalat Cc patents expire, and what generic alternatives are available?

Adalat Cc is a drug marketed by Norwich and is included in one NDA.

The generic ingredient in ADALAT CC is nifedipine. There are thirty-nine drug master file entries for this compound. Thirty-six suppliers are listed for this compound. Additional details are available on the nifedipine profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Adalat Cc

A generic version of ADALAT CC was approved as nifedipine by ACTAVIS ELIZABETH on January 8^th, 1991.

Summary for ADALAT CC

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	165
Clinical Trials:	29
Patent Applications:	3,792
Drug Prices:	Drug price information for ADALAT CC
What excipients (inactive ingredients) are in ADALAT CC?	ADALAT CC excipients list
DailyMed Link:	ADALAT CC at DailyMed

See drug prices for ADALAT CC

See drug sales revenues for ADALAT CC

Recent Clinical Trials for ADALAT CC

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Cao Yu	Phase 1
Jing Liu	Phase 4
Weill Medical College of Cornell University	Phase 4

See all ADALAT CC clinical trials

US Patents and Regulatory Information for ADALAT CC

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Norwich	ADALAT CC	nifedipine	TABLET, EXTENDED RELEASE;ORAL	020198-001	Apr 21, 1993		DISCN	Yes	No
Norwich	ADALAT CC	nifedipine	TABLET, EXTENDED RELEASE;ORAL	020198-002	Apr 21, 1993		DISCN	Yes	No
Norwich	ADALAT CC	nifedipine	TABLET, EXTENDED RELEASE;ORAL	020198-003	Apr 21, 1993		DISCN	Yes	No

Expired US Patents for ADALAT CC

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Norwich	ADALAT CC	nifedipine	TABLET, EXTENDED RELEASE;ORAL	020198-003	Apr 21, 1993
Norwich	ADALAT CC	nifedipine	TABLET, EXTENDED RELEASE;ORAL	020198-001	Apr 21, 1993
Norwich	ADALAT CC	nifedipine	TABLET, EXTENDED RELEASE;ORAL	020198-003	Apr 21, 1993
Norwich	ADALAT CC	nifedipine	TABLET, EXTENDED RELEASE;ORAL	020198-002	Apr 21, 1993
Norwich	ADALAT CC	nifedipine	TABLET, EXTENDED RELEASE;ORAL	020198-002	Apr 21, 1993

International Patents for ADALAT CC

See the table below for patents covering ADALAT CC around the world.

Country	Patent Number	Title	Estimated Expiration
Japan	H09183728	PREPARATION OF SOLID MEDICINE
Japan	H0611699
Germany	3870338
Canada	1180277	MEDICAMENT SOLIDE CONTENANT DE LA NIFEDIPINE ET PROCEDE DE PREPARATION (SOLID MEDICAMENT FORMULATIONS CONTAINING NIFEDIPINE, AND PROCESSES FOR THEIR PREPARATION)
Japan	2955524

ADALAT CC Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Adalat CC (Nifedipine)

Introduction

Adalat CC, a controlled-release formulation of nifedipine, is a crucial medication in the treatment of hypertension and other cardiovascular conditions. Understanding the market dynamics and financial trajectory of Adalat CC is essential for pharmaceutical companies, investors, and healthcare professionals.

Market Size and Growth

The global nifedipine market, which includes Adalat CC, is projected to experience significant growth. By 2032, the market is expected to reach a valuation of USD 1,661.5 million, expanding at a CAGR of 8.1% from 2023 to 2032[1][4].

Key Growth Factors

Prevalence of Cardiovascular Diseases

The increasing prevalence of cardiovascular diseases such as hypertension and angina drives the demand for nifedipine. As chronic long-term illnesses become more prevalent globally, the need for effective treatments like Adalat CC rises[1][4].

Patient Adherence and Compliance

Patient adherence to prescribed medications is a critical factor. Strategies to improve patient education and compliance can positively influence the market by ensuring consistent usage of Adalat CC[1].

Generic Competition and Pricing

The availability of generic nifedipine formulations impacts the pricing and competition within the market. Generic versions often result in lower prices, making the drug more accessible to a larger population. This competition can influence the pricing strategies of existing market players[1].

Technological Advancements

Advances in pharmaceutical technologies, such as improved drug delivery systems, can enhance the efficacy and convenience of Adalat CC. New formulations that reduce side effects or offer better dosage options can gain significant market share[1].

Regulatory Environment

Changes in regulatory policies and approvals can affect the market dynamics of Adalat CC. Updates in safety standards or new indications approved by regulatory bodies can impact market growth and competitiveness[1].

Emerging Markets and Healthcare Infrastructure

Growing healthcare infrastructure in emerging markets and increased awareness about cardiovascular health contribute to the expansion of the nifedipine market. Access to healthcare services and medications in developing countries drives market growth[1][4].

Competitive Landscape

Product Differentiation

Adalat CC, developed by Miles (now part of Bayer), differs from other nifedipine products like Procardia XL (Pfizer) in its pharmacokinetic profile. Adalat CC uses a "Coat Core" delivery system, which depends on gastrointestinal acid for disintegration, unlike the water osmosis system used in Procardia XL. This difference affects the rate and level of drug absorption into the patient's bloodstream[2].

Marketing and Promotional Activities

The competitive landscape is also influenced by marketing and promotional activities. For instance, Miles' promotional materials for Adalat CC were challenged by Pfizer for being misleading, as they implied bioequivalence with Procardia XL, which was not the case[2].

Financial Performance

Current Market Valuation

In 2023, the global nifedipine market, including Adalat CC, is projected to reach a valuation of USD 824.3 million. This valuation is expected to grow significantly to USD 1,661.5 million by 2032[1].

Regional Market Share

North America is the largest market for nifedipine, including Adalat CC, and is expected to grow at a CAGR of 8.5% over the forecast period. The Asia-Pacific region is the fastest-growing market, with a CAGR of 8.8%, driven by increasing healthcare access and infrastructure development[4].

Revenue from Generic and Branded Products

The revenue from Adalat CC and other nifedipine products is influenced by the presence of generic competitors. For example, Teva Pharmaceutical Industries has an exclusive US distribution agreement for several generic products, including nifedipine, which affects the market dynamics and revenue streams[5].

Impact of COVID-19

The COVID-19 pandemic has had both positive and negative impacts on the nifedipine market. On one hand, the pandemic has increased the prevalence of acute and chronic health issues, driving up the demand for medications like Adalat CC. On the other hand, economic downturns and changes in healthcare spending have affected the affordability and accessibility of these medications[1].

Regulatory and Legal Considerations

FDA Approvals and Labeling

Adalat CC received FDA approval in 1993 for the treatment of hypertension, with specific labeling that highlights its unique pharmacokinetic profile. The FDA has strict guidelines for labeling and advertising, which companies must adhere to avoid legal issues[2][3].

Legal Disputes

The market for Adalat CC has been subject to legal disputes, particularly regarding promotional activities. Pfizer challenged Miles' promotional campaign for Adalat CC, alleging that it was misleading and violated the Lanham Act. Such legal battles can impact market dynamics and company strategies[2].

Technological and Formulation Advancements

Drug Delivery Systems

Adalat CC uses a controlled-release formulation that provides once-daily dosing, reducing fluctuations in plasma concentration compared to immediate-release formulations. This formulation enhances patient compliance and efficacy[3].

Pharmacokinetics

The pharmacokinetic profile of Adalat CC, including its elimination half-life and peak plasma concentrations, is distinct from other nifedipine products. This profile affects how the drug is absorbed and metabolized, influencing its therapeutic effects[3].

Regional Market Analysis

North America

North America is the largest market for nifedipine, driven by high rates of chronic illnesses such as hypertension and obesity. The region is expected to continue growing at a CAGR of 8.5% over the forecast period[4].

Asia-Pacific

The Asia-Pacific region is the fastest-growing market, driven by increasing healthcare access, infrastructure development, and telemedicine adoption. India's National Health Policy aims to reduce early cardiovascular deaths, further boosting the demand for nifedipine in this region[4].

Key Takeaways

• The global nifedipine market, including Adalat CC, is projected to grow significantly, reaching USD 1,661.5 million by 2032.
• The market is driven by the prevalence of cardiovascular diseases, patient adherence, generic competition, and technological advancements.
• Regulatory and legal considerations, including FDA approvals and labeling, play a crucial role in market dynamics.
• Regional markets, particularly North America and the Asia-Pacific, are key drivers of growth.
• The unique pharmacokinetic profile of Adalat CC differentiates it from other nifedipine products.

FAQs

What is the projected market size of the global nifedipine market by 2032?

The global nifedipine market is expected to reach a valuation of USD 1,661.5 million by 2032[1].

What are the key factors driving the growth of the nifedipine market?

Key factors include the prevalence of cardiovascular diseases, patient adherence to medications, generic competition, technological advancements, and growing healthcare infrastructure in emerging markets[1].

How does Adalat CC differ from other nifedipine products like Procardia XL?

Adalat CC uses a "Coat Core" delivery system, which differs from the water osmosis system used in Procardia XL, resulting in different pharmacokinetic profiles[2].

What impact did the COVID-19 pandemic have on the nifedipine market?

The pandemic increased the demand for nifedipine due to rising chronic health issues but also affected affordability and accessibility due to economic changes[1].

Which region is expected to be the fastest-growing market for nifedipine?

The Asia-Pacific region is anticipated to exhibit the fastest growth, with a CAGR of 8.8% over the forecast period[4].

Sources

1. Custom Market Insights: "Global Nifedipine Market Size Reach $1,661.5 Million 2032"[1]
2. Casetext: "Pfizer, Inc. v. Miles, Inc."[2]
3. FDA: "Adalat CC (nifedipine) tablets label"[3]
4. Straits Research: "Nifedipine Market Size, Share, Trends, Forecast Report 2032"[4]
5. Teva Pharmaceutical Industries: "Teva Pharmaceutical Industries Ltd. announces 1999 second-quarter and six-month financial results"[5]